ABLATION DEVICE WITH DRUG DELIVERY COMPONENT
An ablation system includes a source of electrosurgical energy, a source of coolant fluid, and an ablation electrode assembly operatively connected to the source of electrosurgical energy and fluidly-coupled to the source of coolant fluid. The ablation electrode assembly includes a hub defining a chamber therein and one or more electrically-conductive ablation needles extending from the hub. The ablation system also includes one or more delivery needles extending from the hub. The one or more delivery needles are selectively moveable from a first position, wherein the distal end of the delivery needle is disposed proximal to the distal end portion of the ablation needle, to at least a second position, wherein at least the distal end of the delivery needle is disposed distally beyond the distal end portion of the ablation needle.
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The present application claims priority to, and the benefit of, U.S. Provisional Application Ser. No. 61/653,804, filed on May 31, 2012, and U.S. Provisional Application Ser. No. 61/658,577, filed on Jun. 12, 2012, the disclosures of which are herein incorporated by reference in their entireties.
BACKGROUND1. Technical Field
The present disclosure relates to electrosurgical systems and devices for performing medical procedures. The present disclosure relates to the administration of beneficial agents in general, which include any physiologically, pharmacologically active and/or psychotropic substance(s). More particularly, the present disclosure relates to ablation devices with drug delivery components, ablation needles with drug delivery components, and electrosurgical systems including the same.
2. Discussion of Related Art
Electrosurgical instruments have become widely used by surgeons. Electrosurgery involves the application of thermal and/or electrical energy to cut, dissect, ablate, coagulate, cauterize, seal or otherwise treat biological tissue during a surgical procedure. Electrosurgery is typically performed using a handpiece including a surgical instrument (e.g., end effector, ablation probe, or electrode) adapted to transmit energy to a tissue site during electrosurgical procedures, an electrosurgical generator operable to output energy, and a cable assembly operatively connecting the surgical instrument to the generator.
Treatment of certain diseases requires the destruction of malignant tissue growths, e.g., tumors. Electromagnetic radiation can be used to heat and destroy tumor cells. Treatment may involve inserting ablation probes into tissues where cancerous tumors have been identified. Once the probes are positioned, electromagnetic energy is passed through the probes into surrounding tissue.
In the treatment of diseases such as cancer, certain types of tumor cells have been found to denature at elevated temperatures that are slightly lower than temperatures normally injurious to healthy cells. Known treatment methods, such as hyperthermia therapy, heat diseased cells to temperatures above 41° C. while maintaining adjacent healthy cells below the temperature at which irreversible cell destruction occurs. These methods involve applying various forms of energy (e.g., electromagnetic, ultrasonic, etc.) to heat, ablate and/or coagulate tissue. Microwave or radio-frequency energy is sometimes utilized to perform these methods. Radio-frequency (RF) and microwave (MW) energy are electromagnetic radiation in the frequency ranges of 3 kilohertz (kHz) to 300 Megahertz (MHz), and 300 MHz to 300 gigahertz (GHz), respectively. Other procedures utilizing electromagnetic radiation to heat tissue also include coagulation, cutting and/or ablation of tissue.
Electrosurgical devices utilizing electromagnetic radiation have been developed for a variety of uses and applications. A number of devices are available that can be used to provide high bursts of energy for short periods of time to achieve cutting and coagulative effects on various tissues. There are a number of different types of apparatus that can be used to perform ablation procedures. Typically, microwave apparatus for use in ablation procedures include a microwave generator that functions as an energy source, and a microwave surgical instrument (e.g., microwave ablation probe) having an antenna assembly for directing the energy to the target tissue. The microwave generator and surgical instrument are typically operatively coupled by a cable assembly having a plurality of conductors for transmitting microwave energy from the generator to the instrument, and for communicating control, feedback and identification signals between the instrument and the generator.
The basic purpose of both monopolar and bipolar electrosurgery is to produce heat to achieve the desired tissue/clinical effect. In monopolar electrosurgery, devices use an instrument with a single, active electrode to deliver energy from an electrosurgical generator to tissue, and a patient return electrode (usually a plate positioned on the patient's thigh or back) as the means to complete the electrical circuit between the electrosurgical generator and the patient. In bipolar electrosurgery, the electrosurgical device includes two electrodes that are located in proximity to one another for the application of current between their surfaces. Bipolar electrosurgical current travels from one electrode, through the intervening tissue to the other electrode to complete the electrical circuit.
The benefits provided by controlled delivery of active agents for the treatment of injury or disease are well recognized in the art and various approaches have been taken to realize the goal of delivering active agents at desired rates over predetermined periods of time. Various different implantable controlled delivery formulations are known in the art, and various different mechanisms have been employed for delivering active agent from implantable formulations at a controlled rate over time.
Medical imaging has become a significant component in the clinical setting and in basic physiology and biology research, e.g., due to enhanced spatial resolution, accuracy and contrast mechanisms that have been made widely available. Medical imaging now incorporates a wide variety of modalities, e.g., computed tomography (CT) and magnetic resonance imaging (MRI), that noninvasively capture the structure and/or function of the human body. Such images are acquired and used in many different ways including medical images for diagnosis, staging and therapeutic management of malignant disease.
Medical image processing, analysis and visualization play an increasingly useful role in disease diagnosis and monitoring as well as, among other things, surgical planning and monitoring of therapeutic procedures. A contrast agent may used for enhancement of the contrast of structures or fluids within the body (or region of interest) in medical imaging to allow visualization and evaluation of lesions seen minimally, if at all, with imaging alone. There is a continuing need for devices capable of dispensing a contrast agent to enhance the visualization of the lesion during the procedure.
Despite advancements in the use of electrosurgical devices for treating biological tissue, there are still concerns for tumor reoccurrence. A continuing need exists for devices capable of dispensing a controlled delivery formulation of a desired active agent, which may help to reduce or eliminate tumor reoccurrence.
SUMMARYThere is a need for ablation devices capable of dispensing a controlled delivery formulation of a desired active agent. The combination of ablation (e.g., RF ablation and/or microwave ablation) and drug delivery may help to reduce or eliminate tumor reoccurrence. There is a need for an ablation device that is configured to dispense an active agent in a controlled delivery formulation and/or non-active agent (e.g., contrast agent) before, during and/or after ablation, e.g., without the need for further manipulation of the device. A need exists for ablation needles with a drug delivery component.
Electromagnetic energy is generally classified by increasing energy or decreasing wavelength into radio waves, microwaves, infrared, visible light, ultraviolet, X-rays and gamma-rays. As it is used in this description, “ablation procedure” generally refers to any ablation procedure, such as microwave ablation, radio frequency (RF) ablation or microwave ablation-assisted resection.
As it is used in this description, “energy-delivery device” generally refers to any device that can be used to transfer energy from a power generating source, such as a microwave or RF electrosurgical generator, to tissue. For the purposes herein, the term “ablation device” is interchangeable with the term “energy-delivery device.” As it is used in this description, “transmission line” generally refers to any transmission medium that can be used for the propagation of signals from one point to another. A transmission line may be, for example, a wire, a two-wire line, a coaxial wire, and/or a waveguide.
For the purposes of this description, the terms “drug,” “drug agent,” “implantable drug agent,” “active agent,” “beneficial agent,” “therapeutic agent,” “therapeutic molecule,” and the like are used interchangeably herein, and may include, for example, small molecules, proteins, enzymes, hormones, polynucleotides, nucleoproteins, polysaccharides, glycoproteins, lipoproteins, polypeptides, steroids, analgesics, local anesthetics, antibiotic agents, anti-inflammatory corticosteroids, ocular drugs and synthetic analogs of these species. Some examples of drug agents that may be delivered by devices according to embodiments of the present disclosure are provided later in this description.
There is a need for an implantable formulation that provides pharmacokinetic/pharmacodynamic (PK/PD) appropriate release rate profile of an active agent without necessarily requiring the need for further manipulation, post implantation or surgical explantation. There is a need for a formulation to facilitate delivery of a wide range of active agents and active agents' formulations, as well as multiple active agents and multiple active agents' formulations, which may also increase the value of each drug-based ablation procedure.
A continuing need exists for systems, devices and methods for controlling and/or monitoring real-time tissue effects to improve patient safety, reduce risk, and/or improve patient outcomes. There is a need for ablation devices capable of dispensing contrast agent to enhance the visualization of the lesion during the treatment procedure.
According to an aspect of the present disclosure, an ablation device is provided. The ablation device includes a handle assembly, an ablation electrode extending from the handle assembly, and one or more delivery needles extending from the handle assembly. The ablation electrode includes an ablation needle. The ablation needle includes a distal end portion including a drug delivery port defined therethrough.
According to an aspect of the present disclosure, an ablation device is provided. The ablation device includes a handle assembly and an array of ablation electrodes operably associated with the handle assembly. One or more ablation electrodes of the array of ablation electrodes include a recess defined therein. A drug is disposed at least in part within the recess.
According to an aspect of the present disclosure, an ablation system is provided. The ablation system includes a source of electrosurgical energy, a source of coolant fluid, and an ablation electrode assembly operatively connected to the source of electrosurgical energy and fluidly-coupled to the source of coolant fluid. The ablation electrode assembly includes a hub defining a chamber therein and one or more electrically-conductive ablation needles extending from the hub. The ablation system also includes one or more delivery needles extending from the hub. The one or more delivery needles are selectively moveable from a first position, wherein the distal end of the delivery needle is disposed proximal to the distal end portion of the ablation needle, to at least a second position, wherein at least the distal end of the delivery needle is disposed distally beyond the distal end portion of the ablation needle.
Objects and features of the presently-disclosed ablation devices with drug delivery (and/or contrast agent) components, ablation needles with drug delivery components, and electrosurgical systems including the same will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which:
Hereinafter, embodiments of the presently-disclosed ablation devices with drug delivery and/or contrast agent components, ablation needles with drug delivery and/or contrast agent components (e.g., suitable for use with Cool-Tip™ RF ablation devices), and electrosurgical systems including the same are described with reference to the accompanying drawings. Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and as used in this description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to that portion of the device, or component thereof, closer to the user and the term “distal” refers to that portion of the device, or component thereof, farther from the user.
This description may use the phrases “in an embodiment,” “in embodiments,” “in some embodiments,” or “in other embodiments,” which may each refer to one or more of the same or different embodiments in accordance with the present disclosure.
Various embodiments of the present disclosure provide energy-delivery devices including ablation needles with drug delivery and/or contrast agent components. Embodiments may be suitable for use with Cool-Tip™ RF ablation devices. Embodiments may be suitable for utilization in open surgical applications. Embodiments may be suitable for utilization with endoscopic and laparoscopic surgical procedures. Embodiments may be implemented using electromagnetic radiation at microwave frequencies, RF frequencies or at other frequencies.
Various embodiments of the present disclosure provide electrosurgical system including an energy delivery device provided with one or more ablation needles with drug delivery (and/or contrast agent) components. Various embodiments of the presently-disclosed electrosurgical systems may be suitable for microwave ablation and for use to pre-coagulate tissue for microwave ablation assisted surgical resection. Various embodiments of the presently-disclosed electrosurgical systems including an ablation device may include any feature or combination of features of the ablation device embodiments disclosed herein.
Various embodiments of the presently-disclosed ablation needle assembly include an elongated body or shaft portion configured to facilitate delivery of one or more drug agents which may be temperature sensitive into tissue, wherein one or more drug agents may be releaseably disposed over at least a portion of body or shaft portion of the ablation needle assembly itself, and/or one or more drug agents may be releaseably disposed over at least a portion of a sleeve member disposed coaxially around the body or shaft portion of the ablation needle assembly.
Drug agents which may be delivered by devices according to embodiments of the present disclosure include drugs which act on the peripheral nerves, adrenergic receptors, cholinergic receptors, the skeletal muscles, the cardiovascular system, smooth muscles, the blood circulatory system, synoptic sites, neuroeffector junctional sites, endocrine and hormone systems, the immunological system, the reproductive system, the skeletal system, autacoid systems, the alimentary and excretory systems, the histamine system and the central nervous system. Some examples of implantable drug agents which may be delivered by devices according to embodiments of the present disclosure are provided later in this description.
In accordance with various embodiments, the combination of tissue ablation and drug delivery may help to reduce and/or eliminate tumor reoccurrence. In accordance with various embodiments, the combination ablation devices with drug delivery and/or contrast agent components may help to reduce procedure times and/or eliminate the need for a separate drug-delivery device.
An embodiment of an ablation electrode assembly 101, similar to the ablation electrode assembly 110 of the electrosurgical system 100 shown in
In some embodiments, electrosurgical system 100 (also referred to herein as ablation system 100) may include a controller 26 for controlling and/or monitoring the operating parameters of the ablation system 100. In some embodiments, as shown in
As seen in
Ablation electrode assembly 110 includes an insulative coating 122 over at least a portion of the length of the ablation needle 112. In some embodiments, the insulative coating 122 is disposed over substantially the length of the ablation needle 112. In some embodiments, as shown in
In some embodiments, as shown in
Referring to
Heat strap 124 is fabricated from a highly heat-conductive anisotropic material, e.g., graphite fiber. Accordingly, in use, the heat strap 124 draws heat away from distal end portion 118 of the ablation needle 112 and dissipates the heat along a length thereof. In order to increase the efficiency and the rate of heat dissipation, a cooling fluid may be circulated over the proximal end 124b of the heat strap 124.
Hub 130 may have a variety of suitable shapes, e.g., cylindrical, rectangular, etc. Hub 130 generally includes a hub body 145 defining a chamber 132 therein. In some embodiments, as shown in
In operation, coolant fluid “F” is communicated into the chamber 132 through the inlet conduit 134 and out of the chamber 132 through the outlet conduit 136. Coolant fluid “F” may be any suitable fluid that can be used for cooling the ablation needle 112, e.g., deionized water, or other suitable cooling medium. As coolant fluid “F” is circulated through the chamber 132 of the hub 130, heat or energy is withdrawn from the proximal end 124b of the heat strap 124 and carried away with fluid flow, e.g., to the fluid source 48 for re-cooling and the like.
In some embodiments, as shown in
Connected to or within the hub of the high-frequency and/or thermo-sensing electrode 142 are connections, indicated by dashed lines in
Coolant source 48 may include any suitable housing containing a reservoir of coolant fluid “F”. Coolant source 48 stores coolant fluid “F”, and may maintain coolant fluid “F” at a predetermined temperature. For example, the coolant source 48 may include a cooling unit (not shown) that cools the returning coolant fluid “F” from the ablation electrode assembly 110. Ablation system 100 may include a coolant supply system (not shown) adapted to provide the coolant fluid “F”, e.g., from the coolant source 48, to the ablation electrode assembly 110. In some embodiments, one or more components of a coolant supply system may be integrated fully or partially into the electrosurgical power generating source 28.
During ablation, e.g., using the electrosurgical system 100, the ablation electrode assembly 110 is inserted into or placed into the body of a patient, e.g., percutaneously or intraoperatively. A plurality of ablation electrodes 110 may be placed in variously arranged configurations to substantially simultaneously ablate a target tissue region, making faster procedures possible. Ultrasound or computed tomography (CT) guidance may be used to accurately guide the ablation electrode assembly 110 into the area of tissue to be treated. Electrosurgical power generating source 28 may be the source of high-frequency voltage which produces the high-frequency current that emanates from the distal end portion 118 of ablation needle 112. Following treatment or ablation of the target tissue, ablation electrode assembly 110 may be withdrawn from the target site and introduced into another target site, into the same target site from a different angle or approach, or in substantially the same location.
Examples of electrosurgical generators that may be suitable for use as the electrosurgical power generating source 28 include generators sold by Covidien Surgical Solutions of Boulder, Colo., e.g., FORCE EZ™ electrosurgical generator, FORCE FX™ electrosurgical generator, and FORCE TRIAD™ electrosurgical generator FORCE IC™ generator, FORCE 2™ generator, SurgiStat™ II, or other generators which may perform different or enhanced functions.
In alternative embodiments not shown, the ablation electrode assembly 110 may include an inflatable balloon member which may be connected to walls of the electrode assembly 110 using any fastening technique, e.g., adhesive, sonic welding, or by any other suitable process. The inflatable balloon member (not shown) may be operated in conjunction with the delivery of a drug agent. The walls of the electrode assembly 110 may be provided with an opening or port disposed and configured to place a inflation lumen in fluid communication with the inflatable balloon member, e.g., to allow drug-delivery flow supplied via the inflation lumen to be used to operate the inflatable balloon member, e.g., drug-eluting balloon. In some embodiments, the electrode assembly 110 may be adapted to allow user control of operational characteristics of the drug-eluting balloon, e.g., rate of inflation, inflation volume, and pressure exerted by the inflatable balloon member on the tissue surrounding the inflatable balloon member.
Cannula body “C” includes an elongated ablation electrode 211 formed of conductive material, e.g. metal such as stainless steel, titanium, etc. Electrode 211 may include a substantially hollow tubular body sized in length and diameter to fit within the cannula body “C”. At the distal end of the cannula body “C”, the electrode 211 defines a tip 212. In operation when using an RF power supply 216, electrical current spreads from the tip 212 to pass through the surrounding tissue causing the tissue to heat up.
Electrode 211 carries an insulative coating 213 over a portion of its length for selectively preventing the flow of electrical current from the shaft 215 of electrode 211 into surrounding tissue. Insulative coating 213 shields the intervening tissue from RF current, so that tissue along the length of the shaft 215 is not substantially heated except by the heating effect from the exposed tip 212.
The proximal end of the electrode 211 is integral with an enlarged housing 214 of the hub “H”, which carries electrical and coolant connections as described below. In the portion disposed outside the patient's body, the housing 214 is of cylindrical configuration, defining ports for connections to the support components “S”, e.g., electrical and fluid couplings. Housing 214 may be integral with the electrode 211, formed of metal, or it may constitute a separate subassembly as described below. Housing 214 may be formed of plastic, and may accommodate separate electrical connections. In that regard, a plastic housing 214 is amenable to low artifact imaging by X-rays CT, MRI, etc. as may be desirable in some situations.
The housing 214 mates with a block 218 defining a luer taper lock 219 sealing the block 218 to the housing 214. Connection to a regulated RF power source 216 may take the form of a standard cable connector, a leader wire, a jack-type contact or other designs. The temperature-sensing and radiofrequency electrical connections may be made through the housing 214 and extend to the region of the tip 212, where an RF line 225 is connected by junction 221, e.g., a weld, braze, or other secure electrical connection. In some embodiments, sensor lines 224 extend to a thermo-sensor 223, e.g., a thermistor, or a thermocouple, or any other type of temperature sensing device capable of sending a signal indicative of a temperature. Thermo-sensor 223 may be fused or in thermal contact with the wall of the tip 212 to sense the temperature of the tip 212.
RF power source 216 may be referenced to reference potential, as illustrated
As indicated above and in accordance with common practice, when the ablation electrode 211 is in a patient's body, an electrical circuit is completed through the body to a reference or dispersive electrode R (symbolically represented in
In accordance herewith, temperatures at, or near the tip 212 (e.g., manifest by the temperature monitor 220) may be controlled by controlling the flow of coolant fluid through the ablation electrode 211. In this manner, the temperature of the surface area of the tip 212 in contact with tissue is controllable. In an embodiment, fluid from a fluid source “FS” is carried the length of the ablation electrode 211 through a tube 226 extending from the housing 214 to the distal end of the electrode 211 terminating in an open end 228 at the tip 212. At the proximal end of the electrode 211, within the housing 214, the tube 226 is connected to receive coolant fluid. Fluid flow may be regulated in accordance with the sensed temperature sensed at the tip 212, allowing increased flow of RF energy.
The fluid coolant may take the form of water or saline for the convection removal of heat from the tip 212. A reservoir or source unit for supplying coolant fluid may be a large reservoir of cooled water, saline or other fluid. As an illustrative example, a tank of water with ice cubes can function to maintain the coolant at a temperature of approximately 0° C. As another example, the fluid source “FS” could incorporate a peristaltic pump or other fluid pump, or could merely be a gravity feed for supplying fluid from a bag or rigid tank.
Flow from the tip 212 to the hub “H” exits the hub “H” through an exit port 240 as illustrated by arrows 242 and 243. The port 240 may take the form of couplings, rigid units or may include flexible tubular couplings to reduce torque transmission to the electrode 211. The coolant flow members may take the form of PVC tubes with plastic luer connectors for ease of use.
As a result of the coolant flow, the interior of the electrode 211, e.g., the electrode tip 212, can be maintained at a temperature near that of the fluid source “FS”. The coolant may circulate in a closed system as illustrated in
The temperature distribution in the tissue near the tip 212 generally depends on the RF current from the radiating section “R” and/or tip 212 and on the temperature of the tissue which is adjacent to the radiating section “R” and/or tip 212. The tip temperature can be controlled to approach the temperature of the fluid from the source “FS”. In this manner, a thermal boundary condition may be established, holding the temperature of the tissue near the radiating section “R” and/or tip 212 to approximately the temperature of the tip itself, e.g., the temperature of the coolant fluid inside the tip 212. Accordingly, by temperature control, a surgeon may impose a defined temperature at the boundary of the electrode radiating section “R” and/or tip 212 which can be somewhat independent of the RF heating process and may significantly modify the temperature distribution in the tissue.
In some embodiments, as shown in
In some embodiments, as shown in
Handle assembly 450 generally includes a handle body 451 configured to support the ablation electrodes 110 and the delivery needle 401 at the distal end 417 thereof. Handle assembly 450 includes a slideably moveable member 460 adapted to allow the user to selectively move the delivery needle 401, e.g., from at least the first configuration to at least the second configuration. Slideably moveable member 460 may include a button 461 having a desired ergonomic form operably associated with the handle body 451. The button 461 may be configured to allow the user to selectively initiate/activate the delivery of drug and/contrast agent from the supply line 414 to the integral needle 401.
Handle assembly 450 may have various configurations. In some embodiments, the handle body 451 defines therein a handle-body chamber 476 having an interior space configured to accommodate one or more components of the ablation device 510, e.g., a hub (e.g., hub “H” shown in
Handle assembly 450 or portions thereof, may be formed from two housing halves (not shown). Each half of the housing may include a series of mechanical interfacing components (not shown) configured to matingly engage with a corresponding series of mechanical interfaces (not shown) to align the two housing halves about the inner components and assemblies of the ablation device 510. It is contemplated that the housing halves (as well as other components described herein) may be assembled together with the aid of alignment pins, snap-like interfaces, tongue and groove interfaces, locking tabs, adhesive ports, etc., utilized either alone or in combination for assembly purposes.
Ablation electrodes 110 are operatively connected to the electrosurgical power generating source 28, and may be disposed in fluid communication with the coolant source 48. A transmission line 15 may be provided to electrically-couple the ablation device 510 to an electrosurgical power generating source (e.g., electrosurgical power generating source 28). Transmission line 15 may additionally provide a conduit (not shown) configured to provide coolant from a coolant source, e.g., deionized water, or other suitable cooling medium, for cooling one or more components of the ablation device 510, such as the ablation electrodes 110. In some embodiments, as shown in
A drug and/or contrast agent supply line 414 may be provided to fluidly-couple the ablation device 510 to a source of the drug and/or contrast agent delivery supply for supplying drugs and/or contrast agent to the handle assembly 450 and/or the integral needle 401. Handle assembly 450 may include one or more fluid conduits (not shown) associated with the handle body 451 configured to provide fluid communication between the supply line 414 and the integral needle 401. Transmission line 15 may additionally, or alternatively, provide a conduit (not shown) configured to provide drugs and/or contrast agent from a source of the supply line 414 to the handle assembly 450 and/or the integral needle 401.
In some embodiments, handle-body chamber 476 may include an interior space configured to accommodate a housing (not shown) containing a reservoir of drugs. In such case, handle body 451 may be provided with an opening covered by a removable cover plate, e.g., to allow removal of the housing containing a reservoir of the drug delivery supply.
In some embodiments, electrosurgical system 500 (also referred to herein as ablation system 500) may include a controller 26 for controlling and/or monitoring the operating parameters of the ablation system 500. In some embodiments, as shown in
Shaft portion 614 defines therein a first fluid-flow path 636, a second fluid-flow path 634 fluidly-coupled to the first fluid-flow path 636, and the needle passageway 611 of generally tubular shape configured to receive the delivery needle 601 slideably moveably therein. Although the passageway 611 is generally tubular-shaped, other shapes can be used depending on the configuration of the delivery needle 601.
As seen in
First fluid-flow path 636, e.g., leading to the distal end portion 618 of the ablation needle 600, and the second fluid-flow path 634, e.g., leading away from the distal end portion 118, are configured to provide fluid flow of a coolant fluid “F”, e.g., deionized water, or other suitable cooling medium, for cooling at least the distal end portion 618 of the ablation needle 600. In some embodiments, first fluid-flow path 636 and/or the second fluid-flow path 634 are fluidly-coupled to a hub (e.g., hub 130 shown in
Ablation needle 600 may be configured to be operatively coupleable to a handle assembly of an ablation device, which may be configured to support the ablation needle 600. In some embodiments, the ablation device (e.g., ablation device 510 shown in
The delivery needle 601 may include micro-needle arrays disposed in association with a surface of the delivery needle 601. Micro-needle arrays may be made from electrical and/or temperature sensitive materials, and may be oriented in any suitable manner.
As seen in
The recesses 830 are provided with one or more drugs, which may be temperature-sensitive, therein. In some embodiments, the recesses 830 are provided with microspheres, e.g., API or CTA microspheres and/or microparticles, and may be provided with a thermo-sensitive binding agent, e.g., wax. In some embodiments, the recesses 830 are provided with one or more chemotherapeutic agents, and may be provided with a thermo-sensitive binding agent. A thermo-sensitive binding agent may be combined with the microspheres, API, or CTA disposed in the recesses 830. A thermo-sensitive binding agent may additionally, or alternatively, be formed as layered coating to protect and/or postpone delivery of the microspheres, API, or CTA.
In some embodiments, as shown in
The recesses 930 are provided with one or more drugs 834 therein, such as without limitation, microspheres, chemotherapeutic agents, and/or a thermo-sensitive binding agent, e.g., wax. Recesses 930 are similar to the recesses 830 shown in
Sleeve member 1070 is configured to be disposed coaxially around at least a portion of the body or shaft portion 1001. Recesses 1030 may be provided with one or more drugs 834 therein. Any suitable number of the same or different drug reservoir divots 1031 may be utilized.
The body or shaft portion 1001 is operatively connected to an electrosurgical power generating source (e.g., electrosurgical power generating source 28 shown in
Sleeve member 1170 may be configured to be disposed coaxially around the body or shaft portion 1001, or portion thereof. Recesses 1130 may be provided with one or more drugs 834 therein. Any suitable number of the same or different drugs may be utilized, e.g., depending upon a particular purpose and/or to achieve a desired surgical outcome.
Sleeve member 1170 additionally, or alternatively, includes one or more apertures 1190 defined therethrough. Apertures 1190 are configured to allow electromagnetic energy, e.g., microwave energy, to be delivered to tissue. In some embodiments, as shown in
Sleeve member 1270 may be configured to be disposed coaxially around the body or shaft portion 1001, or portion thereof. Recesses 1230 may be provided with one or more drugs 834 therein. Any suitable number of the same or different drugs may be utilized.
As seen in
Rod member 1307 is coupled at its distal end to the tip portion 1323 and configured to be slideably moveable within the shaft portion 1340. This arrangement permits relative longitudinal movement of the rod member 1307 to effect movement of the tip portion 1323. As seen in
Although five tendrils and/or projections 1385 are shown in
In some embodiments, the tendrils and/or projections 1385 may additionally, or alternatively, be configured to break off and become implanted into target tissue, e.g., tumor. The tendrils and/or projections 1385 may be implanted permanently, or until degraded, dissolved and/or absorbed. In some embodiments, the tendrils and/or projections may be made of biodegradable material to degrade over time while releasing one or drugs. In some embodiments, the tendrils and/or projections 1385 may have a micro-needle array on the surface of the tendrils and/or projections to further penetrate the tissue and/or tumor with drug (e.g., API, CTA, and/or suspended microspheres).
As seen in
Tendrils 1485 may be made of biodegradable material to degrade over time while releasing one or drugs. In some embodiments, the tendrils 1485 may be configured to inject API, CTA, and/or suspended microspheres. Tendrils 1485 may additionally, or alternatively, have a coating thereon to facilitate penetration into the tissue and/or tumor. In some embodiments, the tendrils 1485 may include one or more micro-needle arrays associated therewith to further penetrate the tissue and/or tumor with drug (e.g., API, CTA, and/or suspended microspheres). Tendrils 1485 may additionally, or alternatively, be configured to break off and become implanted into target tissue, e.g., tumor.
Moveable member 1407 is selectively moveable from at least a first configuration, as seen in
Barrel portion 1627 defines a chamber 1630 therein. The chamber 1630 is configured to house the RF antenna filaments 1612. The antenna filaments 1612 can break off to act as implantable filaments. The mechanism of the antenna filaments breaking off may be done in two steps: (1) the inner conductor 1610 is moved distally from the moveable tip portion 1623; and (2) the antenna filaments 1612 break off because of the tension that is created between the top edge of the moveable tip 1623 and the inner conductor 1610. The top edge of the moveable tip 1623 may additionally, or alternatively, be machined to have a razor sharp edge to help facilitate the separation of the antenna filaments 1612.
Referring to
Referring to
Referring to
In some embodiments, ablation device 1900 may include a hub 1930. Hub 1930 may provide electrical and/or coolant connections to the antenna assembly 1914, and may be configured to support the antenna assembly 1914. Hub 1930 may have a variety of suitable shapes, e.g., cylindrical, rectangular, etc. Hub 1930 generally includes a hub body 1945 defining a chamber 1932 therein. In some embodiments, as shown in
Referring to
In some embodiments, electrosurgical system 3600 (also referred to herein as ablation system 3600) may include a controller 26 for controlling and/or monitoring the operating parameters of the ablation system 3600. In some embodiments, as shown in
Ablation electrode assembly 110 includes an elongated ablation needle 112. In some embodiments, coolant fluid (and/or drug agent) may circulate to a tip portion for cooling of the ablation needle 112. One or more sensors may be utilized to measure temperatures at various locations in the proximity of the tip portion. One or more sensor devices, or components thereof, may be disposed outside the distal end portion 118 of the ablation needle 112. The sensed temperature may be utilized to control the flow of energy and/or the flow of coolant to attain the desired ablation while maintaining the maximum temperature substantially below a predetermined temperature, e.g., 100° C.
In some embodiments, ablation device 10 is adapted to allow the user to selectively position the delivery needle 101 from one or more first configurations, wherein the distal end 123 of the delivery needle 101 is positioned proximal to the distal end portion 118 of the ablation needles 112, to one or more second configurations, wherein at least the distal end 123 of the delivery needle 101 is positioned distally beyond the distal end portion 118 of the ablation needles 112. Ablation device 10 may additionally, or alternatively, be adapted to allow the user to selectively position the antenna assembly 2014 from one or more first configurations, wherein the distal end of the antenna assembly 2014 and/or the delivery needle 2023 is positioned proximal to the distal end portion 118 of the ablation needles 112, to one or more second configurations, wherein at least the distal end of the antenna assembly 2014 and/or the delivery needle 2023 is positioned distally beyond the distal end portion 118 of the ablation needles 112.
Handle assembly 150 generally includes a handle body 151 configured to support the ablation electrodes 110, the delivery needle 101, and the antenna assembly 2014 at the distal end 117 of the handle body 151. Handle assembly 150 includes a slideably moveable member 160 adapted to allow the user to selectively move the delivery needle 101 and/or the antenna assembly 2014 and/or the delivery needle 2023. Slideably moveable member 160 may include one or more buttons having a desired ergonomic form operably associated with the handle body 151. In some embodiments, as shown in
In some embodiments, transmission line 15 may provide a conduit (not shown) configured to provide coolant from a coolant source, e.g., deionized water, or other suitable cooling medium, for cooling one or more components of the ablation device 10, such as the ablation electrodes 110. Transmission line 15 may additionally, or alternatively, provide a conduit (not shown) configured to provide drugs and/or contrast agent to the handle assembly 150 and/or the delivery needle 101 and/or the delivery needle 2023.
A drug and/or contrast agent supply line 14 may be provided to fluidly-couple the ablation device 10 to a source of the drug and/or contrast agent delivery supply for supplying drugs and/or contrast agent to the handle assembly 150 and/or the delivery needle 101 and/or the delivery needle 2023. Handle assembly 150 may include one or more fluid conduits (not shown) associated with the handle body 151 configured to provide fluid communication between the supply line 14 and the delivery needle 101 and/or the delivery needle 2023.
During ablation, e.g., using the electrosurgical system 3600, the ablation electrodes 110 and the antenna assembly 2014 are inserted into or placed into the body of a patient, e.g., percutaneously or intraoperatively. Ultrasound or computed tomography (CT) guidance may be used to accurately guide the ablation electrodes 110 and the antenna assembly 2014 into the area of tissue to be treated. Electrosurgical power generating source 28 may be the source of high-frequency voltage which produces the high-frequency current that emanates from the distal end portion 118 of ablation needles 112. Following treatment or ablation of the target tissue, ablation electrodes 110 and the antenna assembly 2014 may be withdrawn from the target site and introduced into another target site, into the same target site from a different angle or approach, or in substantially the same location.
As shown in
A plurality of recesses 3830 is defined in the distal end portion of the insulative coating 122, e.g., proximate to the distal end portion 3818 of the ablation needle 112. The recesses 3830 may be formed in any suitable shape, and may define receptacles of any suitable volume to contain one or more drugs. In some embodiments, as shown in
One or more of the recesses 3830 are provided with one or more drugs 3834 therein, such as without limitation, microspheres, chemotherapeutic agents, and/or a thermo-sensitive binding agent, e.g., wax. In some embodiments, the recesses 3830 are provided with one or more chemotherapeutic agents, and may be provided with a thermo-sensitive binding agent. A thermo-sensitive binding agent may be combined with the microspheres, API, or CTA disposed in the recesses 3830. A thermo-sensitive binding agent may additionally, or alternatively, be formed as layered coating to protect and/or postpone delivery of the microspheres, API, or CTA.
A variety of drug agents may be delivered by devices according to embodiments of the present disclosure. Some examples of drug agents which may be delivered by devices according to embodiments of the present disclosure include chemotherapeutic agents such as without limitation cisplatin, paclitaxel, doxorubicin, fluorouracil, as well as other compounds such as without limitation prochlorperzine edisylate, ferrous sulfate, aminocaproic acid, mecamylamine hydrochloride, procainamide hydrochloride, amphetamine sulfate, methamphetamine hydrochloride, benzamphetamine hydrochloride, isoproterenol sulfate, phenmetrazine hydrochloride, bethanechol chloride, methacholine chloride, pilocarpine hydrochloride, atropine sulfate, scopolamine bromide, isopropaniide iodide, tridihexethyl chloride, phenformin hydrochloride, methylphenidate hydrochloride, theophylline cholinate, cephalexin hydrochloride, diphenidol, meclizine hydrochloride, prochlorperazine maleate, phenoxybenzamine, thiethylperzine maleate, anisindone, diphenadione erythrityl tetranitrate, digoxin, isofluorophate, acetazolamide, methazolamide, bendroflumethiazide, chloropromaide, tolazamide, chlormadinone acetate, phenaglycodol, allopurinol, aluminum aspirin, methotrexate, acetyl sulfisoxazole, erythromycin, hydrocortisone, hydrocorticosterone acetate, cortisone acetate, dexamethasone and its derivatives such as betamethasone, triamcinolone, methyltestosterone, 17-S-estradiol, ethinyl estradiol, ethinyl estradiol 3-methyl ether, prednisolone, 17-oc-hydroxyprogesterone acetate, 19-nor-progesterone, norgestrel, norethindrone, norethisterone, norethiederone, progesterone, norgesterone, norethynodrel, aspirin, indornethacin, naproxen, fenoprofen, sulindac, indoprofen, nitroglycerin, isosorbide dinitrate, propranolol, timolol, atenolol, aiprenolol, cimetidine, clonidine, imipramine, levodopa, chlorpromazine, methyldopa, dihydroxyphenylalanine, theophylline, calcium gluconate, ketoprofen, ibuprofen, cephalexin, erythromycin, haloperidol, zomepirac, ferrous lactate, vincamine, diazepam, phenoxybenzamine, diltiazem, mitrinone, capropril, mandol, quanbenz, hydrochlorothiazide, ranitidine, flurbiprofen, fenufen, fluprofen, tolmetin, alciofenac, mefenamic, flufenamic, difiuinal, nimodipine, nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine, tiapamil, gallopamul, amlodipine, mioflazine, lisinoipril, enalapril, enalaprilat, captopril, ramipril, famotidine, nizatidine, sucralfate, etintidine, tetratolol, minoxidil, chlordazepoxide, diazepam, amitriptyline, and imipramine; opioids such as meperidine, hydrocodone, oxycodone, and semi-synthetic opioids such as oxymorphone, hydromorphone, opiates such as morphine and codeine, opioid antagonists such as without limitation naltrexone, nalbuphine, naloxone as well as opioid agonist/antagonist compounds such as buprenorphine, and synthetic analgesics such as methadone, tramadol, fentanyl and sufentanil.
Some other examples of drug agents which may be delivered by devices according to embodiments of the present disclosure include vitamin and supplements such as vitamins B-12 (cyanocobalamin) and D2, anti-virals such as without limitation acyclorvir and zidovudine; proteins and peptides such as without limitation insulin, colchicine, glucagon, thyroid stimulating hormone, parathyroid and pituitary hormones, calcitonin, renin, prolactin, corticotrdphin, thyrotropic hormone, follicle stimulating hormone, chorionic gonadotropin, gonadotropin releasing hormone, bovine somatotropin, porcine somatotropin, oxytocin, vasopressin, GRE, prolactin, somatostatin, lypressin, pancreozymin, luteinizing hormone, LHRH, LHRH agonists and antagonists, leuprolide, interferons, interleukins, growth hormones such as human growth hormone, bovine growth hormone and porcine growth hormone, fertility inhibitors such as the prostaglandins, fertility promoters, growth factors, coagulation factors, human pancreas hormone releasing factor, analogs and derivatives of these compounds, and pharmaceutically acceptable salts of these compounds, or their analogs or derivatives. On the molecular level, the various forms of the beneficial agent may include uncharged molecules, molecular complexes, and pharmaceutically acceptable acid addition and base addition salts such as hydrochlorides, hydrobromides, acetate, sulfate, laurylate, oleate, and salicylate. Examples of acidic compounds which may be delivered by devices according to embodiments of the present disclosure include salts of metals, amines or organic cations. Derivatives such as esters, ethers and amides may also be used.
A drug agent for delivery by devices according to embodiments of the present disclosure may be used alone or mixed with other agents. A drug agent for delivery by the presently-disclosed devices may include pharmaceutically acceptable excipients, polymeric carriers and/or additional ingredients, such as antioxidants, stabilizing agents, permeation enhancers, polysaccharides, proteins, nucleotides like aptamers, and fatty acids, etc., and fabricated into different forms, such as solution, suspension, gel, colloidal dispersion like liposome, or micro- and nano-particles for controlled delivery of the drug agent. A drug agent for delivery by the presently-disclosed devices may include a thermo-sensitive metal depositor or any such compound that increases the sensitivity of the target tissue, e.g., tumor, to ablation.
A drug agent for delivery by the presently-disclosed devices may include a cryoablation agent, e.g., liquid nitrogen, and may prove complementary to thermal ablation that uses electrosurgical energy at RF or microwave frequencies.
The above-described systems and ablation devices may offer improved anti-cancer efficacy with RF ablation (or microwave ablation) and localized drug delivery capabilities integrated into a single medical device. In accordance with the above-described systems and ablation devices, an approach is taken to deliver drug formulation(s) locally when the anatomical access has already been obtained for the purpose of RF or microwave ablation, which, in turn, presents the prospect of reduced side-effects associated with systemic administration of the same drug molecule(s).
In accordance with the above-described systems and ablation devices, heat activated drugs may be delivered to the periphery of the tumor, which may not get as hot as the center of the tumor, to ensure adequate margins. The above-described systems and ablation devices may be used to kill tumors from the inside out, wherein the temperature at the periphery may not be high enough to destroy the tumor through ablation (e.g., in some cases, requiring temperatures of at least 55° C.), but at high enough temperature (e.g., in some cases, temperatures of about 45° C.) to activate one or more drugs delivered by the above-described ablation devices, which may take care of killing the tumor edges.
Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited thereby. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.
Claims
1. An ablation device, comprising:
- a handle assembly;
- an ablation electrode extending from the handle assembly, the ablation electrode including an ablation needle, wherein the ablation needle includes a distal end portion including a drug delivery port defined therethrough; and
- at least one delivery needle extending from the handle assembly.
2. The ablation device of claim 1, wherein the handle assembly is adapted to allow the user to selectively position the at least one delivery needle in tissue.
3. The ablation device of claim 2, wherein the at least one delivery needle is selectively moveable from a first position, wherein a distal end of the at least one delivery needle is disposed proximal to a distal end portion of the ablation electrode, to at least a second position, wherein at least the distal end of the at least one delivery needle is disposed distally beyond the distal end portion of the ablation electrode.
4. The ablation device of claim 1, wherein the at least one delivery needle includes a micro-needle adapted to be slideably moveable within the at least one delivery needle.
5. The ablation device of claim 1, further comprising an antenna assembly extending from the handle assembly, wherein the antenna assembly includes a delivery needle adapted to be slideably moveable within the antenna assembly.
6. The ablation device of claim 5, wherein the handle assembly is adapted to allow the user to selectively position the antenna assembly in tissue.
7. An ablation device, comprising:
- a handle assembly; and
- an array of ablation electrodes operably associated with the handle assembly, wherein at least one ablation electrode of the array of ablation electrodes includes a recess defined therein, and wherein a drug is disposed at least in part within the recess.
8. The ablation device of claim 7, further comprising an antenna assembly extending from the handle assembly, wherein the antenna assembly includes a delivery needle.
9. An ablation system, comprising:
- a source of electrosurgical energy;
- a source of coolant fluid;
- an ablation electrode assembly operatively connected to the source of electrosurgical energy and fluidly-coupled to the source of coolant fluid, the ablation electrode assembly including:
- a hub defining a chamber therein;
- at least one electrically-conductive ablation needle extending from the hub, the ablation needle including a distal end portion; and
- at least one delivery needle extending from the hub, the at least one ablation needle including a distal end, wherein the at least one delivery needle is selectively moveable from a first position, wherein the distal end of the at least one delivery needle is disposed proximal to the distal end portion of the at least one ablation needle, to at least a second position, wherein at least the distal end of the at least one delivery needle is disposed distally beyond the distal end portion of the at least one ablation needle.
10. The ablation system of claim 9, wherein the delivery needle is integral to the ablation needle.
11. The ablation system of claim 9, further comprising a first conduit fluidly-coupled to the hub for delivering fluid into the chamber thereof from the source of coolant fluid; and a second conduit fluidly-coupled to the hub for draining fluid from the chamber thereof.
12. The ablation system of claim 9, wherein the distal end portion of at least one electrically-conductive ablation needle includes a drug delivery port defined therethrough.
13. The ablation system of claim 9, wherein the at least one delivery needle includes a micro-needle adapted to be slideably moveable within the at least one delivery needle.
14. The ablation system of claim 13, wherein the handle assembly is adapted to allow the user to selectively position the micro-needle in tissue.
15. The ablation system of claim 9, wherein the at least one electrically-conductive ablation needle includes a recess defined therein, and wherein a drug is disposed at least in part within the recess.
Type: Application
Filed: May 29, 2013
Publication Date: Dec 5, 2013
Applicant: COVIDIEN LP (Mansfield, MA)
Inventors: RACHIT OHRI (FRAMINGHAM, MA), LAN PHAM (NASHUA, NH), PHILLIP D. BLASKOVICH (SALEM, MA), LES HULL (ATTLEBORO, MA), RUPAL AYER (BOULDER, CO), STEPHEN H. WU (CHESTERFIELD, MO), CLIFFORD J. HERMAN (SAINT LOUIS, MO), WILLIAM H. NAU, Jr. (LONGMONT, CO), FRANCESCA ROSSETTO (LONGMONT, CO), ALLISON WALLER (BLACKSTONE, MA), RICHARD HUANG (SHANGHAI), PAUL DICARLO (MIDDLEBORO, MA)
Application Number: 13/904,478
International Classification: A61B 18/14 (20060101); A61M 5/158 (20060101);